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Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients (HERACLES-HFpEF)

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ClinicalTrials.gov Identifier: NCT04782908
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Philipp Lurz, Heart Center Leipzig - University Hospital

Study Description
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Brief Summary:
The aim of the study is to investigate the pathophysiological implications of transcatheter tricuspid valve edge-to-edge repair in patient with heart failure and preserved ejection fraction and severe tricuspid regurgitation. Changes in right- and left-ventricular function as well as the interventricular dependence will be analysed on a multimodal basis including pressure-volume loop analysis and cardiac magnetic resonance imaging.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Tricuspid Regurgitation Device: Transcatheter tricuspid valve edge-to-edge repair Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients undergoing transcatheter tricuspid valve edge-to-edge repair will undergo multimodal cardiovascular diagnostics before and after tricuspid valve repair including pressure volume loop analysis and cardiac magnetic resonance imaging
Masking: None (Open Label)
Masking Description: Outcome assessors will be blinded whether they are analysing pre or post transcatheter tricuspid valve edge-to-edge repair data.
Primary Purpose: Diagnostic
Official Title: Hemodynamic Characterisation of Patients Undergoing Transcatheter Tricuspid Valve Edge-to-edge Repair in Patients With Severe Tricuspid Regurgitation and Heart Failure With Preserved Ejection Fraction
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Transcatheter tricuspid valve edge-to-edge repair
Patients will undergo transcatheter tricuspid valve edge-to-edge repair (TTVR) and hemodynamic characteristics will be analysed on a multimodal approach using cardiac magnetic resonance imaging and pressure volume loop analysis before and after TTVR.
 Device: Transcatheter tricuspid valve edge-to-edge repair
Transcatheter tricuspid valve edge-to-edge repair is an interventional approach to treat severe tricuspid regurgitation. Under general anesthesia a clip delivery system is forwarded through the vena femoralis and right atrium in the right ventricle. A clip is deployed to clamp the tricuspid valve and reduce tricuspid valve regurgitation.


Outcome Measures
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Primary Outcome Measures :
  1. Periprocedural change in enddiastolic pressure volume relationship of the left ventricle [ Time Frame: Periprocedural. ]
    Change in the ratio of pressure to volume of the left ventricle before and after TTVR. Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.


Secondary Outcome Measures :
  1. Change in the estimated left ventricular end diastolic volume at 10 mmHg as estimated by the left ventricular pressure volume relationship (LVEDPVR) [ Time Frame: Periprocedural. ]
    Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.

  2. Change in the ratio of isovolumetric relaxation constant "Tau" and duration of diastole of the left ventricle. [ Time Frame: Periprocedural. ]
    Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.

  3. Change in dPdtmin [ Time Frame: Periprocedural. ]
    Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software.

  4. Change in the early diastolic filling pattern as assessed by MRI. [ Time Frame: Baseline and 1-month follow-up following TTVR. ]
    All patients will receive MRI before and 1-month after TTVR on a 1.5 tesla scanner.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe tricuspid regurgitation with need for interventional treatment approach as decided by an interdisciplinary heart team.
  • Signs and symptoms of left-sided heart failure.
  • Left-ventricular ejection fraction ≥50%
  • Invasive evidence of elevated left-ventricular fillings pressures (pulmonary capillary wedge pressure [PCWP] or left-ventricular end-diastolic pressure ≥15 mmHg)

Exclusion Criteria:

  • Concomitant relevant mitral valve regurgitation with need for concomitant interventional treatment
  • Moderate aortic stenosis.
  • Pregnancy
  • Contraindication to perform cardiac magnetic resonance imaging.
  • Conditions rendering patient unable to give informed consent to the study protocol.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04782908


Contacts
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Contact: Karl-Patrik Kresoja, MD 0341865252596 karl-patrik.kresoja@medizin.uni-leipzig.de
Contact: Philipp Lurz, MD, PhD 0341865252529 philipp.lurz@medizin.uni-leipzig.de

Locations
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Germany
Heart Centre at University Leipzig Recruiting
Leipzig, Saxony, Germany, 04289
Contact: Karl-Patrik Kresoja, MD    0341 865 252596    karl-patrik.kresoja@medizin.uni-leipzig.de   
Contact: Philipp Lurz, MD, PhD    0341 865 252529    philipp.lurz@medizin.uni-leipzig.de   
Sub-Investigator: Karl-Philipp Rommel, MD         
Sub-Investigator: Christian Besler, MD         
Sub-Investigator: Matthias Unterhuber, MD         
Sponsors and Collaborators
Heart Center Leipzig - University Hospital
More Information
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Responsible Party: Philipp Lurz, Professor, Managing Senior Physician, Heart Center Leipzig - University Hospital
ClinicalTrials.gov Identifier: NCT04782908    
Other Study ID Numbers: HERACLES-HFpEF
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Anonymized data will be made available on reasonable cooperation request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philipp Lurz, Heart Center Leipzig - University Hospital:
Heart failure with preserved ejection fraction
tricuspid regurgitation
transcatheter tricuspid valve edge-to-edge repair
Additional relevant MeSH terms:
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Heart Failure
Tricuspid Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases